FDA Product Code PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
FDA product code PKC covers uncemented metal total anatomic shoulder prostheses cleared for shoulder arthroplasty.
These implants achieve fixation through biological ingrowth or ongrowth into porous-coated surfaces rather than bone cement. Uncemented fixation is preferred in younger, more active patients where long-term biological fixation may outperform cemented alternatives.
PKC devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Tornier, Inc. and Lima Corporate S.P.A..
FDA 510(k) Cleared Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained Devices (Product Code PKC)
About Product Code PKC - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code PKC since 2015, with 19 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PKC have taken an average of 142 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
PKC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →